Pharma Compliant Weighing and Sample Management

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Quality Control in the biopharmaceutical industry includes the testing of raw materials, product intermediates and final drug products to ensure they meet the specifications related to their safety, stability, and efficacy. Typical quality control processes that we support with our high-end laboratory balances include sample preparation and management. 

See how we can address your weighing challenges in your QC process.

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Intuitive Workflows Ensure Safety

Cubis® II balances were designed for intuitive operation, aided by intelligent assistant systems. This is not only includes an on-board QApp center but other features like status center, gesture control, automated motorized leveling and isoCal function, build-in-ionizer, climate module, which all contribute to the correct usage of the balances. 

This guarantees a higher degree of repeatability of the different workflows, while lowering the probability of human error during the measurement steps. 

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Sartorius’s Cubis® II is designed to follow data integrity principles.

65% of all warning letters issued by the FDA in 2017 were related to data integrity issues—from not documenting batch related activities and backdating of data to transferring data incorrectly or an insufficient audit trail (1).

To address these issues, Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) principles are incorporated into the Cubis® II balance, offering a full form of compliance to adhere to all necessary data integrity regulations. 

With a pharmaceutical package, the Cubis® II balance offers users all the technical controls necessary to support compliance with common regulations such as FDA’s (21 CFR Part 11) and EU’s (Annex 11). These controls include audit trail, safe data transfer, backups, time synchronization, e-signatures, access control and user management, and alibi memory, a timestamp electronic log file that allows reconstruction of events related to the creation, modification, or deletion of records. 

Cubis® II Connectivity & Compliance

Cubis® II Connectivity & Compliance


Cubis® II - Pharma Compliant by Design
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Pharma Compliant Weighing Resources

21 CFR Part 11 Compliance Checklist

The Cubis®️ II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Full compliance...

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Magnetism - An Influencing Factor on Weighing

Magnetism and electricity are natural phenomena, which have been known since ancient times. In 1820, Danish physicist Hans Christian Oersted...

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Integration of Sartorius Cubis® II into STARLIMS™ from Abbott...

Direct instrument integration into a LIMS is an essential task to reduce the need for manual recording, which negates the potential for errors...

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Formulation QApps Using a Database with Cubis®️ II

This is the use case description for the QApps Formulation flexible tare and Formulation single vessel. Both of these QApps have the ability to...

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Pipette Check to Standard DIN with Cubis®️ II

According to Standard DIN EN ISO 8655-2 volumetric measuring instruments such as piston pipettes must be checked at regular intervals but at...

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Tablet Check: Check of Tablets and Capsules with Cubis® II

According to European pharmacopoeia to ensure the consistency of dosage units tablets and capsules containing 25 mg or more of an active...

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Application Article: Effects of Static Electricity on Analytical Weighing

Effects of Static Electricity on Analytical Weighing

Among the various options for eliminating static electricity during analytical weighing, there are simple, low-cost measures available. However...

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Average Weight Control of Prepackaged Goods and Drugs Application...

For more than 150 years, Sartorius has provided high-quality weighing technology for laboratory and production environments.

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Discover How Omnis and Cubis II Can Help You With Your Karl Fisher Titration Method!

Seamless Integration of Cubis® II into Metrohm OMNIS Analytical Software System

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